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The Anatomical Location, Cellular Origin and Molecular Basis of Gut-derived Glucagon Secretion

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Mille Baekdal Nielsen, University Hospital, Gentofte, Copenhagen
Sponsor:
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
Mille Baekdal Nielsen, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT03181191
First received: June 6, 2017
Last updated: June 9, 2017
Last verified: June 2017
  Purpose
Delineation of the anatomical location, cellular origin and molecular basis of gut-derived glucagon secretion

Condition Intervention
Glucose Metabolism Disorders Other: Oral glucose tolerance test

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Anatomical Location, Cellular Origin and Molecular Basis of Gut-derived Glucagon Secretion

Resource links provided by NLM:


Further study details as provided by Mille Baekdal Nielsen, University Hospital, Gentofte, Copenhagen:

Primary Outcome Measures:
  • gut-derived glucagon [ Time Frame: 1 year ]
    The primary objective is to investigate mucosal biopsies from specific regions of the upper gastrointestinal tract


Secondary Outcome Measures:
  • Oral glucose tolerance test [ Time Frame: 45 minutes ]
    Glucose metabolism - hormones, insulin, glucagon, glp-1


Estimated Enrollment: 24
Actual Study Start Date: April 27, 2017
Estimated Study Completion Date: December 31, 2018
Estimated Primary Completion Date: December 31, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Totally pancreatectomised patients
Oral glucose tolerance test and biopsies
Other: Oral glucose tolerance test
Oral glucose tolerance test and biopsies
Active Comparator: Type 2 diabetes patients
Oral glucose tolerance test and biopsies
Other: Oral glucose tolerance test
Oral glucose tolerance test and biopsies
Active Comparator: Healthy control subjects
Oral glucose tolerance test and biopsies
Other: Oral glucose tolerance test
Oral glucose tolerance test and biopsies

Detailed Description:

Aim: to delineate the anatomical origin, the molecular structure and precursors, the regulation and the (patho-) physiological implications of gut-derived glucagon.

Eight totally pancreatectomised patients, eight type 2 diabetes patients and eight healthy controls (age 18-80, BMI <30) with normal kidney and liver parameters and hgb> 6.5 - will be included. The participants will each undergo one screening day and one study day including a gastroduodenoscopy. Multiple biopsies will be taken at several predefined locations in the upper gastrointestinal tract. These biopsies will be analysed with different techniques including immunohistochemical staining, quantitative polymerase chain reaction (qPCR-) analyses and more to search for glucagon. After the last biopsy has been collected, 50 g of glucose dissolved in 100 ml water is infused through the enteroscope into the most proximal part of the small intestine. Hereafter blood samples for glucagon and gut hormone analyses will be collected 15, 30 and 45 min after the glucose infusion.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • normal kidney function, normal liver function, normal hemoglobin levels

Exclusion Criteria:

  • diabetes type 1, first degree relatives with type 2 diabetes
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03181191

Contacts
Contact: Mille Baekdal, MD +45 26700782 mille.baekdal.nielsen@regionh.dk
Contact: Filip Knop, MD, PhD filipknop@dadlnet.dk

Locations
Denmark
Center for Diabetes Research Recruiting
Hellerup, Denmark, 2900
Contact: Mille Baekdal, MD    +45 26700782    mille.baekdal.nielsen@regionh.dk   
Contact: Filip Knop, MD, PhD       filipknop@dadlnet.dk   
Sponsors and Collaborators
Mille Baekdal Nielsen
University of Copenhagen
Investigators
Study Director: Filip Knop, MD, PhD University Hospital, Gentofte, Copenhagen
  More Information

Responsible Party: Mille Baekdal Nielsen, MD, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT03181191     History of Changes
Other Study ID Numbers: UHG-CFD-PX-BIOPSY
Study First Received: June 6, 2017
Last Updated: June 9, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Metabolic Diseases
Glucose Metabolism Disorders
Glucagon
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 18, 2017